ConstipationNCT01874301
Probiotics and Gut Health
A study testing High quantity probiotic and Low quantity probiotic in people with Constipation, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
Trial summary
Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the major contributors to Gastrointestinal discomfort is constipation, which has a prevalence of ~15%, and symptoms of which have a significant negative impact on the sufferer's quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Constipation
- What is being tested?
- High quantity probiotic and Low quantity probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women
- female subjects of child-bearing potential must be willing to use a reliable method of contraception throughout the study period
- Age 18 - 65
- BMI: 18.5 - 29.9 kg/m2
- Symptoms of constipation for a minimum of 3 months
- Recruitment based on simplified core ROME III diagnostic criteria for functional constipation (based on specific screening questions):a). average Bristol stool type of 1 - 4 AND frequency of 1 - 3 spontaneous bowel movements (SBMs) per week b). plus at least ONE of: straining on at least 25% of defaecations; sensation of incomplete evacuation on at least 25% of defaecations; sensation of anorectal obstruction / blockage on at least 25% of defaecations; use of manual manoeuvres on at least 25% of defaecations.
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- Cleveland Clinic constipation score (CCCS) of 8-15
- Willing and able to consume a milk-based product daily for 4 weeks
- Low-moderate fibre intake (≤18g) determined by the semi-quantitative food intake screener known as the Block Fibre Screener
- No regular use of fibre supplementation (e.g. Fybogel, Lactulose) over the week prior to the screening visit, and no more than 6 standard doses in the past 1 month prior to the screening visit. Also, willing to discontinue fibre supplementation and other probiotics, prebiotics, fermented milk, yoghurt or laxatives at least 2 weeks prior to and during the consumption phase and the follow-up phase
- Ability to understand the patient information sheet and instructions in English, and able to provide informed consent
Who cannot join
- Subjects who report lactose intolerance and/or are allergic to cow milk protein or soya
- Regular consumption of probiotics, fibre supplements (including prebiotics), fermented milk, yogurt, laxatives, or those unwilling to discontinue these at least 2 weeks prior to and during the study
- Pregnant or breast-feeding women
- Ongoing other diagnosed gastrointestinal disease or complication (e.g. IBS, Crohn's disease, Coeliac disease, chronic diarrhoea, etc.)
- Any clinical relevant abnormalities in the screening visit medical examination or alarm features such as sudden unintentional weight loss, rectal bleeding, recent change in bowel habit (<3 months), abdominal pain and stool positive for occult blood
- Prior abdominal surgery (including gastric bypass or laparoscopic banding), except cholecystectomy and appendicectomy
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- Neurologic diseases such as multiple sclerosis, stroke, spinal cord injury, Hirschsprung disease
- Ongoing therapy with drugs known to affect gut motility, such as prokinetic agents (such as metoclopramide, domperidone, erythromycin, azithromycin), anti-emetic agents, anxiolytics (such as benzodiazepines), antidepressive agents (such as trycyclics, SSRI's etc.), narcotic analgesic agents (such as methadone, fentanyl), anticholinergic agents for IBS, medications for constipation (including enemas, cathartics, polyethylene glycol solutions), 5HT3 antagonists, anti-diarrheal agents (such as loperamide), opiate agents used to treat diarrhoea, NSAIDs (more than once daily), other antibiotics taken during or within 4 weeks of study onset, magnesium-containing antacids
- Illness that may preclude the subject's ability to complete the study or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness, severe cardiovascular disease, chronic renal failure or eating disorders) or any other serious illness resulting in >2 weeks inability to work in the 3 months before the study start
- Subjects with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect gut motility or limit normal functions (e.g. reduced mobility or increased fragility)
- HADS score of >11
- Ongoing alcohol, drug, or medication abuse
- Self-reported symptoms of pelvic organ prolapse
- Moderate or severe active local anorectal problems such as recurrent anal fissures, bleeding, large prolapsing haemorrhoids, etc
- Participation in another study with any investigational product within 3 months of screening
- Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wingate Institute, Queen Mary University of London
London, E1 2AJ
About this study
Official title: Evaluation of Changes in Gut Transit Time and Gastrointestinal Symptoms Following the Consumption of a Probiotic Food Product in Adults With Constipation
Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the major contributors to Gastrointestinal discomfort is constipation, which has a prevalence of ~15%, and symptoms of which have a significant negative impact on the sufferer's quality of life. One of the hallmarks of chronic constipation is slow progression of contents through the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that are difficult to expel. Previous studies have shown that probiotics improve colonic transit times in constipated patients. In addition, several other studies, employing a range of different probiotic strains, have shown a significant increase in defaecation frequency and improvement in stool consistency. However, the clinical relevance of these results is uncertain, due to small sample sizes and limitations in study methodology. The current study is designed to compare changes in gut transit time and gastrointestinal symptoms following 4 weeks consumption of a probiotic strain in a randomized, double-blind, placebo-controlled manner, in adults with constipation.
Read the detailed description
This is an adaptive, parallel, double-blinded, randomized, placebo-controlled, stratified clinical study, comparing three study arms (two quantities of the probiotic active component and one placebo)with equal allocation ratio. Recruitment of subjects to the low quantity of the probiotic will be after fulfilling certain criteria at interim. After half of the subjects in the two study groups of high quantity and placebo have completed the study (40 subjects), an interim analysis will be performed. Depending on the observed effect size and the conditional power, the study may be stopped for futility, continued with the two groups or continued with inclusion of the third group of low dose probiotics.
- Conditions
- Constipation
- Being tested
- High quantity probiotic, Low quantity probiotic, placebo
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High quantity probioticOther
The intervention type is food product
Low quantity probioticOther
The intervention type is food product
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| High quantity probiotic food product | Experimental | Not described Receives: Other: High quantity probiotic |
| Low quantity probiotic food product | Experimental | Not described Receives: Other: Low quantity probiotic |
| Placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole gut transit time- 2 groups
To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing probiotics in high quantity, compared to those consuming placebo
Measured: After 2 weeks consumption of the study product
Secondary outcomes (11)
Regional colonic transit time- all groups
To evaluate change in the regional (right colon, left colon, and rectosigmoid)transit time 2 weeks after consumption of the study product in all groups
Measured: After 2 weeks consumption of the study product
Whole gut and Regional colonic transit time- all groups
To evaluate the whole gut and regional colonic transit time after 4 weeks consumption of the study product in all study groups
Measured: After 4 weeks consumption of the study product
Whole gut transit time- all groups
To evaluate change in whole gut transit time 2 weeks after consumption of the study product in all groups
Measured: After 2 weeks consumption of the study product
Response to the Patient assessment of constipation symptoms (PAC-SYM) - all groups
To evaluate change in Gastrointestinal symptoms 2\&4 weeks after consumption of the study product in all groups
Measured: After 2&4 weeks consumption of the study product
Cleveland Clinic constipation score - all groups
To evaluate change in Gastrointestinal symptoms 2\&4 weeks after consumption of the study product in all groups
Measured: After 1&2&4 weeks consumption of the study product
Stool frequency- all groups
Assessed through daily bowel diary records for each bowel movement
Measured: After 2&4 weeks consumption of the study product
Stool consistency - all groups
To evaluate stool form (Bristol stool scale) 2\&4 weeks after consumption of the study product in all groups
Measured: After 2&4 weeks consumption of the study product
Response to the constipation quality of life (PAC-QOL)questionnaires - all groups
To evaluate change in quality of life 2\&4 weeks after consumption of the study product in all groups
Measured: After 2&4 weeks consumption of the study product
Tolerance to the study product- all groups
Response to tolerance questionnaire 2\&4 weeks after consumption of the study product in all groups
Measured: After 2&4 weeks consumption of the study product
Global Constipation Symptom Score - all groups
To evaluate change in Gastrointestinal symptoms 2\&4 weeks after consumption of the study product in all groups
Measured: After 1&2&4 weeks consumption of the study product
Ease of passage - all groups
Assessed through daily bowel diary records for each bowel movement
Measured: After 2&4 weeks consumption of the study product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Scott, PhD, Principal investigator, Wingate Institute, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874301
- Sponsor's protocol ID
- 12.05.NRC
- Status last verified
- Nov 2015
- First submitted
- 31 May 2013
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Gut Transit Time and Gastrointestinal Symptoms Following the Consumption of a Probiotic Food Product in Adults With Constipation
- ClinicalTrials.gov ID
- NCT01874301
- Acronym / sponsor ID
- 12.05.NRC
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the major contributors to Gastrointestinal discomfort is constipation, which has a prevalence of ~15%, and symptoms of which have a significant negative impact on the sufferer's quality of life. One of the hallmarks of chronic constipation is slow progression of contents through the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that are difficult to expel. Previous studies have shown that probiotics improve colonic transit times in constipated patients. In addition, several other studies, employing a range of different probiotic strains, have shown a significant increase in defaecation frequency and improvement in stool consistency. However, the clinical relevance of these results is uncertain, due to small sample sizes and limitations in study methodology. The current study is designed to compare changes in gut transit time and gastrointestinal symptoms following 4 weeks consumption of a probiotic strain in a randomized, double-blind, placebo-controlled manner, in adults with constipation.
Detailed description
This is an adaptive, parallel, double-blinded, randomized, placebo-controlled, stratified clinical study, comparing three study arms (two quantities of the probiotic active component and one placebo)with equal allocation ratio. Recruitment of subjects to the low quantity of the probiotic will be after fulfilling certain criteria at interim. After half of the subjects in the two study groups of high quantity and placebo have completed the study (40 subjects), an interim analysis will be performed. Depending on the observed effect size and the conditional power, the study may be stopped for futility, continued with the two groups or continued with inclusion of the third group of low dose probiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High quantity probiotic food product | Experimental | Other: High quantity probiotic |
| Low quantity probiotic food product | Experimental | Other: Low quantity probiotic |
| Placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult men or women
- female subjects of child-bearing potential must be willing to use a reliable method of contraception throughout the study period
- Age 18 - 65
- BMI: 18.5 - 29.9 kg/m2
- Symptoms of constipation for a minimum of 3 months
Key exclusion criteria (16 listed)
- Subjects who report lactose intolerance and/or are allergic to cow milk protein or soya
- Regular consumption of probiotics, fibre supplements (including prebiotics), fermented milk, yogurt, laxatives, or those unwilling to discontinue these at least 2 weeks prior to and during the study
- Pregnant or breast-feeding women
- Ongoing other diagnosed gastrointestinal disease or complication (e.g. IBS, Crohn's disease, Coeliac disease, chronic diarrhoea, etc.)
- Any clinical relevant abnormalities in the screening visit medical examination or alarm features such as sudden unintentional weight loss, rectal bleeding, recent change in bowel habit (<3 months), abdominal pain and stool positive for occult blood
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High quantity probioticThe intervention type is food product | Other | High quantity probiotic food product |
| Low quantity probioticThe intervention type is food product | Other | Low quantity probiotic food product |
| placebo | Other | Placebo |
Primary outcome
Whole gut transit time- 2 groups
Time frame: After 2 weeks consumption of the study product
To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing probiotics in high quantity, compared to those consuming placebo
11 secondary outcomes
Regional colonic transit time- all groups
Time frame: After 2 weeks consumption of the study product
Whole gut and Regional colonic transit time- all groups
Time frame: After 4 weeks consumption of the study product
Whole gut transit time- all groups
Time frame: After 2 weeks consumption of the study product
Response to the Patient assessment of constipation symptoms (PAC-SYM) - all groups
Time frame: After 2&4 weeks consumption of the study product
Cleveland Clinic constipation score - all groups
Time frame: After 1&2&4 weeks consumption of the study product
Stool frequency- all groups
Time frame: After 2&4 weeks consumption of the study product
Stool consistency - all groups
Time frame: After 2&4 weeks consumption of the study product
Response to the constipation quality of life (PAC-QOL)questionnaires - all groups
Time frame: After 2&4 weeks consumption of the study product
Tolerance to the study product- all groups
Time frame: After 2&4 weeks consumption of the study product
Global Constipation Symptom Score - all groups
Time frame: After 1&2&4 weeks consumption of the study product
Ease of passage - all groups
Time frame: After 2&4 weeks consumption of the study product
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Scott, PhD principal investigator
Wingate Institute, Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High quantity probiotic and Low quantity probiotic in people with Constipation, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole gut transit time- 2 groups (time frame: After 2 weeks consumption of the study product). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.